The Nanotechnology-Biology Interface: Exploring Models for Oversight

The Nanotechnology-Biology Interface:Exploring Models for OversightSeptember 15, 2005Workshop ReportEditor, Jennifer KuzmaCenter for Science, Technology, and Public Policy

IntroductionNanotechnology, or really any technology, does not exist in a vacuum. It is derivedfrom human efforts and affected by social, cultural, and political climates. Yet, fewtechnologies emerge with the societal consequences in mind. Social and economic issuesoften gain most attention after technologies enter the marketplace and are widely used.Within the U.S. National Nanotechnology Initiative (NNI), resources have been directedtowards the investigation of the societal issues that might accompany the applications ofnanotechnology on their road to development and use. Approximately 4% of NNI fundinghas been used to study the social, educational, and ethical implications of nanotechnology. 1Many experts in this area have cited negative experiences with past technologies, such asstem cell research and genetic engineering, as the impetus for dealing with the contextualissues for nanotechnology early and often.Society drives and regulates technology, attempting to minimize the downsides andmaximize the benefits. Appropriate oversight of new technologies is important forensuring the health and environmental safety of products and instilling public confidence.Most people agree that ultimately the success of any technology is dependent on propergovernance within a societal context. Mishaps or accidents can preclude future use anddevelopment, and there is a delicate balance between allowing technology to flourish andputting regulatory or non-regulatory oversight systems in place.Discussions of oversight frameworks for nanotechnology have largely focused onoccupational health issues associated with engineered nanoparticles, such as buckyballsand carbon nanotubes. 2 Less attention has been paid to widespread applications inmedicine, food and agriculture, and the environment, for which consumers, patients,ecosystems, farmers, or the general public may bear the risks and benefits. Several of these“nano-bio” applications are already entering the marketplace, while others are emergingin development and clinical trial phases. However, there have not been many focusedpublic conversations on appropriate oversight frameworks for them. It is in this context,that the Center for Science, Technology, and Public Policy hosted the workshop “TheNanotechnology-Biology Interface: Exploring Models for Oversight” on September 15,2005. 3Kenneth H. Keller, moderator of the workshop and Charles M. Denny, Jr. Professorof Science, Technology, and Public Policy at the University of Minnesota, opened theworkshop by describing our recent paradigm shift as a society from a reductionist approachin science, in which a phenomenon is largely considered on its own in the laboratory, toa systems approach, in which there is recognition that every part of one phenomenoninteracts with another. This systems approach can be extended to connect technology withits context in society. In other words, how we govern social, economic and political systemsaffects what happens to technology. He framed the workshop along two general themes:1Roco, M.C. “The emergence and policy implications of converging new technologies integrated from thenanoscale.” Journal of Nanoparticle Research 7:129-143 (2005).22 nd International Symposium on Nanotechnology and Occupational Health, University of Minnesota, October 3-6,2005.3In a public workshop, over 160 people from academe, industry, state and federal government, tradeorganizations, law and venture capital firms, and the general public convened to discuss governance issuesfor the nano-bio interface. The day following the public workshop, approximately 35 speakers and otherexperts continued the discussions. The workshop was funded by the Consortium on Law and Values in Health,Environment, and the Life Sciences. http://www.lifesci.consortium.umn.edu/.1

1) anticipating consequences and understanding interconnections, as people feel moreconfident about new technologies when we are proactively and openly thinking about theirpossible effects; and 2) evaluating whether existing governance systems fit the features,many of them novel, of emerging technologies. More specifically, the workshop addressedthe following questions:• Is there or will there be a mis-match between the ability to generate nanoparticlesand the ability to detect or determine the effects of these particles? Should the two belinked in any regulations developed with respect to nanoparticle use?• Are there procedures developed for other technologies that could or should beadopted or adapted to assure the safety of nanoparticles and materials developedfrom them? What is the appropriate balance between government regulation andinvestigator or industry voluntary guidelines?• What is the relationship between claims made for the potential of nanotechnologyand the challenge of building public confidence in the safety of it? What is theappropriate strategy for balancing these two factors to preserve momentum in thedevelopment of the technology?• If new governance models are designed, or existing ones revised, what is theappropriate process? What scientific, economic, social, and other factors should beconsidered? Who should be involved in developing the models?This report highlights key points of discussion from the workshop and the opportunitiesand challenges associated with oversight at the nano-bio interface. It is organized aroundthe themes of the workshop sessions: science and applications at the nano-bio interface,health and environmental safety concerns, regulatory and non-regulatory approaches togovernance, striking an appropriate balance for governance in a societal context, andfar-future applications and how governance systems can account for them. The reportsummarizes each presentation and reflects on the larger ideas in each session. It concludeswith a summary of the general themes that emerged from the workshop. We hope that theworkshop and this report are the beginning of closer examinations of nano-bio governance.Science and ApplicationsSome question how nanotechnology came to be and whether it is really new. Materialsscience, biochemistry, chemical engineering, aerosol science, and particle technologyhave been around for several decades, yet only recently have been included in theforefront of nanotechnology research and development. To better understand the fieldof nanotechnology, the first session of the workshop reviewed specific applicationsof nanotechnology to biology (Table 1) and tackled the question of what makesnanotechnology special.2

Nanotechnology is defined by the NNI as “the understanding and control of matterat dimensions of roughly 1 to 100 nanometers, where unique phenomena enablenovel applications.” 4 Nanomaterials can arise from a “top-down” approach, in whichmacroscopic material is broken down to the nanoscale, or from a “bottom-up” approach,in which individual atoms or molecules are coaxed or self-assemble into nanoparticles.Skeptics believe that as a society we have hijacked many different fields and applicationsand now call it “nanotechnology” as a way to create “hype” and get funding. However,others would argue that in last ten years, we have had better abilities to control,understand, and analyze materials at the nano-scale (Box 1) and that nanomaterialshave special properties; and therefore, a new area is justified. There is disagreement asto whether a precise definition of nanotechnology is necessary for oversight and framingof other contextual issues. Regardless, nanotechnology reflects a multidisciplinaryconglomerate of ideas and methods. In this sense, it is an umbrella that brings peopletogether to solve problems. Secondary effects of bundling various basic researchquestions, fields, disciplines, and applications together include increased collaboration andunderstanding among the actors and scientists involved.4National Nanotechnology Initiative. “What is Nanotechnology?” http://www.nano.gov/html/facts/whatIsNano.html. Accessed November 30, 2005.3

Box 1. Tools of nanotechnologySource: http://www.che.utoledo.edu/nadarajah/webpages/whatsafm.html“The scanning tunneling microscope (STM) and atomic force microscope (AFM)provide pictures of atoms on or in surfaces. A system that uses variations of theprinciples used by an STM or AFM to image surfaces is often called a scanning probemicroscope (SPM).The AFM works by scanning a fine ceramic or semiconductor tip over a surface muchthe same way as a phonograph needle scans a record. The tip is positioned at the endof a cantilever beam shaped much like a diving board. As the tip is repelled by orattracted to the surface, the cantilever beam deflects. The magnitude of the deflection iscaptured by a laser that reflects at an oblique angle from the very end of the cantilever.A plot of the laser deflection versus tip position on the sample surface provides theresolution of the hills and valleys that constitute the topography of the surface. TheAFM can work with the tip touching the sample (contact mode), or the tip can tapacross the surface (tapping mode) much like the cane of a blind person.Other measurements can be made using modifications of the SPM. These includevariations in surface microfriction with a lateral force microscope (LFM), orientationof magnetic domains with a magnetic force microscope (MFM), and differencesin elastic modulii on the micro-scale with a force modulation microscope (FMM).A very recent adaptation of the SPM has been developed to probe differences inchemical forces across a surface at the molecular scale. This technique has been calledthe chemical force microscope (CFM). The AFM and STM can also be used to doelectrochemistry on the microscale.AFM is being used to solve processing and materials problems in a wide range oftechnologies affecting the electronics, telecommunications, biological, chemical,automotive, aerospace, and energy industries. The materials being investigated includethin and thick film coatings, ceramics, composites, glasses, synthetic and biologicalmembranes, metals, polymers, and semiconductors. The AFM is being applied tostudies of phenomena such as abrasion, adhesion, cleaning, corrosion, etching, friction,lubrication, plating, and polishing.”4

The first session of the workshop overviewed applications and implications ofnanotechnology for biology, including the use of nanotechnology in basic biologicalresearch, medicine, agriculture, and the environment. The first speaker, Andrew Taton,Professor of Chemistry at the University of Minnesota, noted that nanomolecules andparticles, such as viruses, molecular motors, and membrane vesicles, exist naturally inbiology, but the new nano-bio interface explores the interactions of the natural withthe man-made. He provided numerous examples of work at this interface (e.g., some ofthose in Table 1) and argued that the nano-scale is unique from a physical standpoint,in that properties change when you whittle size down. He stated that one of the greattechnological challenges right now is to meld inorganic or man-made particles withbiological molecules and make them more compatible. Dr. Taton’s group works on coatingnanoparticles to make them more “biofriendly.” He argued that the nano-bio interface ishere, and that the pace of applying nanotechnology to health is moving very quickly.This rapid emergence creates a host of technical challenges and opportunities. For example,workshop participants discussed whether quantum dots interact with molecules in cells andinterfere with typical cellular reactions. There are studies that indicate that quantum dotsbind cellular components and can be toxic. Dr. Taton’s lab is developing biocompatiblecoatings to prevent such interactions. Dr. Taton stressed the importance of getting togetherin a forum like the workshop to discuss safety and toxicity issues before the widespread useof nanoparticles.Darrell Untereker, Vice President of Corporate Research and Technology at Medtronic,Inc., argued that nanotechnology is not “a technology” per se, but a collection of thingsthat happen at a certain scale. He stated that nanotechnology is not entirely new, andwhen we discuss public policy, it is important that we do not forget that the basic scientificprinciples are the same. For him and others in industry, the primary question is what canbe done with nanotechnology to benefit society. Dr. Untereker described ways in whichthe medical device industry uses nanotechnology, such as for corrosion-resistant devicecoatings, or will use it in the future, such as for nanodevices to detect physiological states ofpatients. He emphasized that there is the possibility of moving faster than wise. However,on the other hand, he stressed that we should not put impediments to moving forward,because future gains to be made from knowledge and applications of nanotechnology gobeyond what we can conceive today.Larry Walker, Professor of Biological and Environmental Engineering at Cornell University,reviewed applications of nanotechnology in industrial biotechnology and agriculture. Hedescribed the many global challenges that we face—the high cost of energy, providing foodto feed increasing populations, and securing safe water—and stressed the increased needfor agriculture to provide raw materials and energy needed for our transition towards asustainable world. Dr. Walker spoke about the use of nanotechnology to better understandhow cellulases work to produce ethanol and identify and quantify naturally-occurringmicroorganisms for generating products and energy from waste (Table 1). He stressedthe importance of working in multidisciplinary teams for the sustainable deployment ofnanotechnology and for American land grant institutions to act as independent sources ofinformation about the benefits and pitfalls of nanotechnology.5

Table 1. A few examples of research and applications at the nano-biointerface(Note: this table does not include all possible categories of applications)Source: compiled by J. Kuzma.Sector Application Method orMaterialDetailsAgricultureBasic Research onEnergy ProductionNanodetectionSingle molecule detection todetermine enzyme/substrateinteractions (e.g., cellulases inproduction of ethanol).Agrochemical DeliveryNanoparticles, nanocapsulesDelivery of pesticides,fertilizers, and otheragrichemicals more efficiently(e.g., only when needed or forbetter absorption).Animal ProductionNanoparticlesDelivery of growth hormone ina controlled fashion.Nanomaterials inchips (nanochips)Identity preservation andtracking.Animal or Plant Health Nanosensors Detect animal pathogens, suchas foot and mouth diseasevirus. Detect plant pathogensearly.Animal MedicineNanoparticles,nanodevicesDeliver animal vaccines.Plant Production Nanoparticles Delivery of DNA to plantstowards certain tissues (i.e.,targeted genetic engineering).Food Sensing Nanosensors Detect chemicals or foodbornepathogens; biodegradablesensors for temperature,moisture history, etc.Safety Nanoparticles Selectively bind and removechemicals or pathogens.Packaging Nanoclays, nanofilms Prevent or respond tospoilage. Sensing features forcontaminants or pathogens.Healthy FoodNanoemulsions,nanoparticlesBetter availability anddispersion of nutrients,nutraceuticals, or additives.6

EnvironmentMicrobial Ecology andCharacterizationMicrofluidics,micro-nano arraysIdentify and quantifymicrobial populations forbiocontrol, composting,bioremediation, etc.(e.g., nano-single strandconformation profiling ofDNA for counting singlemolecules).Sensing Nanosensors Detect environmentalcontaminants early; assessstates of populations orecosystems.Remediation Nanoparticles Bind contaminants andremove them.Medicine Ex vivo Diagnostics Nanoparticle labeledDNAMicroarray analysis formedical genomics (e.g.,detecting patient geneticresponse to pathogens,or tailoring treatments toindividuals).In vivo Diagnostics Nanoparticles Magnetic particles forimaging (e.g., MRI oftumors).Drug Delivery or GeneTherapyTissue ScaffoldNanoparticlesSurfacenanomaterials,nanocoatingsTag particles and target drugsor genes to specific tissues.Increase bioavailabilityor solubility. Make drugsmore bioactive. Liposomes,dendrimers, and otherinorganic or organic particles.Promote cell growth,providing a matrix(e.g., neuron growth onnanofabricated silicon).Medical Devices Nanocoatings Coatings to make devices,such as pacemakers, corrosionresistant and biocompatible.NanosensorsSense chemicals in the bodyand adjust device functionaccordingly.Biology—BasicresearchSensing, Detecting, andCharacterizingCantileversBend in response to molecularinteractions.NanowiresUse nano-conductivity forcharacterizing interactions(e.g., between viruses andproteins).Quantum dotsLabel different cells, proteins,or cellular componentswith colored tags. Trackmovement, relationships, etc.at the subcellular level. Longlifetime is a positive feature ofthese tags.7

Health and Environmental SafetyThe ability to assess the health and environmental impacts of nanoparticles and othernanomaterials is a cornerstone for governance. It is not sufficient, but seems necessaryfor a good oversight framework. Standard models of chemical, ecological, or microbialrisk assessment likely apply to nano-bio products, but within the models, data needs andtechnical questions might be very different given the special biological, chemical, andphysical properties that arise at the nanoscale. In general, we are lacking fundamentalknowledge and data for assessing the potential risks of nanoproducts used in or derivedfrom biological systems. Yet, nanotechnology is now here. At the workshop, currentactivities and studies in environmental health and safety (EHS) research were presented,along with mechanisms and institutions for funding and conducting such work.Nora Savage, Environmental Engineer at the Office of Research Development at theEnvironmental Protection Agency (EPA), discussed EPA’s activities at the nano-biointerface. EPA works through the NNI’s Nanoscale Science, Engineering, and Technologycommittee (NSET), which is responsible for coordinating federal research and developmentat the nanoscale (Figure 1). The National Nanotechnology Coordinating Office (NNCO) isthe point of contact for NSET. Several federal agencies fund EHS research under NNI (Box2). According to Dr. Savage, for fiscal year (FY) 2006, the total NNI budget request wasapproximately $1 billion and NNI EHS research totaled $38.5 million.There is general difficulty in classifying EHS research as “implications” or “applications,”and this is a point of contention in the health and environmental safety community. Forexample, the general development of sensors could be placed in either category. Also,applications research can provide information for implications and vice versa. Dr. Savageindicated that to date, EPA has funded approximately $15.6 million of applicationsresearch to address existing environmental problems or prevent future problems, and it hasfunded $10.2 million in implications research to address the interactions of nanomaterialswith the environment and potential risks. Environmental applications of nanotechnologyinclude improved monitoring and detection capabilities, ultra-green manufacturing andchemical processing, waste minimization, reduced energy usage, clean energy sources,remediation and treatment technologies, and sustainability applications. Implicationsresearch for nanomaterials includes studies on toxicity and its mechanisms; effects ofmanufacturing on ecosystems; transportation and fate of nanomaterials; bioaccumulation,transformation, and availability; and dose-response assessment.Dr. Savage pointed out that many health and environmental applications ofnanotechnology have a dual nature. For example, the ability of nanoparticles to cross theblood-brain barrier has advantages for delivering drugs to the brain, which is an organthat is otherwise difficult to reach, but that same feature amplifies toxicity concerns.In environmental applications, nanomaterials may be used to penetrate and remediatesubsurface areas, but their penetration abilities could also lead to ecosystem damage. Moregenerally, the novel properties and uses of nanotechnology which provide benefits alsocause regulatory concern.8

EPA governs nanotechnology with its mission to protect human health and the environmentin mind. EPA’s nanotechnology framework includes facilitating nanotechnology’s promisefor environmental protection, understanding problems that might arise for health or theenvironment, and considering environmental benefits and impacts from the beginning. Dr.Savage mentioned the UK Royal Society report, 5 which recommended that nanomaterialsnot be used in the environment until we have better understanding of their fate, transport,and effects. The U.S. is not currently taking that approach.5Royal Society of the UK. Nanoscience and Nanotechnologies: Oopportunities and Uncertainties. (2004).http://www.nanotec.org.uk/finalReport.htm Precise recommendation is:“Specifically, in relation to two main sources of current and potential releases of free nanoparticles and nanotubesto the environment, we recommend: (i) that factories and research laboratories treat manufactured nanoparticlesand nanotubes as if they were hazardous, and seek to reduce or remove them from waste streams; (ii) that theuse of free (that is, not fixed in a matrix) manufactured nanoparticles in environmental applications such asremediation be prohibited until appropriate research has been undertaken and it can be demonstrated that thepotential benefits outweigh the potential risks.”9

Figure 1. Federal organizations involved in nanotechnologyOMB, Office of Management and Budget; PCAST, President’s Council of Advisors in Science andTechnology; OSTP, Office of Science and Technology Policy; CSPC, Consumer Product SafetyCommission; EPA, Environmental Protection Agency; FDA, Food and Drug Administration; ITIC,Information Technology Industry Council; NASA, National Aeronautics and Space Administration;NIH, National Institutes of Health; NIOSH, National Institute of Occupational Safety and Health;NIST, National Institute of Standards and Technology; NRC, National Research Council; NSF,National Science Foundation; PTO, Patent and Trademark Organization; DHS, Department ofHomeland Security; DHHS, Department of Health and Human Services; DOC, Department ofCommerce; DOD, Department of Defense; DOE, Department of Energy; DOJ, Department of Justice;DOS, Department of State; DOT, Department of Transportation; DOTreas, Department of theTreasury; USDA, US Department of Agriculture.Source: N. Savage, presentation, September 15, 2005.CongressWhite House/OSTPNanotechnologyEnvironmental and HealthImplications Group (NEHI)Nano Innovation andIndustry Liaison (NIIL)Nano Public EngagementGroup (NPEG)Global Issues InNanotechnology(GIN)OMBPCASTNanoscale Science, Engineering andTechnology SubcommitteeIndependent AgenciesCPSC, EPA, FDA, ITIC,NASA, NIH, NIOSH, NIST,NRC, NSF, OMB, PTODepartmentsDHS, DHHS, DOC, DOD,DOE, DOJ, DOS, DOT.DOTreas, USDA10

Box 2. NNI environmental health and safety researchNTP, National Toxicology Program; see Figure 1 for other abbreviationsSource: N. Savage, presentation, September 15, 2005.NSFBasic research: environmental effects of nanoparticles;nanoparticles in air pollution; water purification; nanoscaleprocesses in the environment.NTP Potential toxicity of nanomaterials, such as titanium dioxide,several types of quantum dots, and fullerenes.DOD Physiochemical characteristics and toxicological properties ofnanomaterials; computational model that will predict toxic,salutary and biocompatible effects based on nanostructuredfeatures.EPAToxicology of manufactured nanomaterials; fate, transport, andtransformation; human exposure and bioavailability.DOE Transport and transformation of nanoparticles in theenvironment; exposure and risk analysis; health effects.NIH Nanomaterials in the body and cell cultures; laboratory use fordiagnostic and research tools.NIST Measurement tools, tests, and analytical methods.11

Jacob Finkelstein, Professor of Pediatrics, Environmental Medicine, and RadiationOncology at the University of Rochester, stressed that we currently do not have enoughinformation to characterize the risks of nanomaterials and devices. We know that there arerisks, but we are just reaching the point now where we can begin to ask the right questionsabout their nature and magnitude. His group develops approaches for risk assessment, notto stifle the technology, but rather with the ultimate goal of appropriately using it.He described the importance of using risk assessment paradigms (Box 3) for evaluating therisks of nanotechnology in a way that is meaningful to regulators. The fundamental use ofparadigms will likely be the same for products of nanotechnology, but data needs may notbe. For example, at the nano-scale, cellular uptake mechanisms are different, as particlesbelow 20 nm can be taken up by the endothelium skin layers and those below 10-50 nmcan enter cells through receptor mechanisms. Nanoparticles have been found to cross theblood-brain barrier (Figure 2, page 14). They also have higher surface areas and greaternumbers of particles at concentrations similar to larger particles. Surface properties aredifferent at the nanoscale, and quantum properties dominate. Therefore, Dr. Finkelsteinargued that the special properties and effects of nanoparticles should be considered andnew strategies in toxicology are needed.Some factors complicating risk assessments include differences in the exposure medium(e.g., air, water, or food), routes of exposure (e.g., inhaled, consumed, or contacted), anddose-response relationships. In certain media, it is not known whether nanomaterialsexist as single particles or agglomerates. Also, there are differences in dose-responsecurves depending on whether the curves are expressed by mass, number of particles, orsurface area. Furthermore, most tests are short-term, and long-term toxicity and effectsremain unknown. Dr. Finkelstein outlined some key questions for toxicology research onnanomaterials:• Which physicochemical characteristics of nanoparticles are associated with adverseeffects? (e.g., size, chemistry, crystallinity, biopersistence, surface coating, porosity, orcharge)• Is cellular uptake involved? If so, what are the uptake and translocationmechanisms?• What should be considered when designing biocompatible nano-sized materials?What would make a toxic nanoparticle biocompatible?Dr. Finkelstein hopes we can define a systematic approach that will help us address thespecial toxicological issues associated with nanotechnology. He proposed a tiered andcombined approach, involving first, detailed physico-chemical characterizations of particlesor other materials, then acellular and cellular assays comparing dose by mass, number, andsurface area, and finally, in vivo assays. He noted that appropriate endpoints for in vitroassays can be difficult to determine, as single cell types are often not relevant, given thatvarious types of tissues are exposed in the body.12

Ideally, adequate information for each step in risk assessment would be available, butfor many nano-products, researchers and regulators are currently relying on qualitativejudgments for nearly every step. Dr. Finkelstein stressed that we need data on what type ofhuman exposure to expect, dose-response relationships, kinetics and cellular interactions,and correlations of properties of materials to their toxicity. His group is developinga relational database to determine organizing principles for assessing toxicity. Groupmembers are systematically looking at a number of different materials and properties tocorrelate those with biological effects. In addition to the work of Dr. Finkelstein, an expertgroup of the International Life Sciences Institute (ILSI) Research Foundation recentlypublished a report on a screening strategy for hazard identification of nanomaterials basedon their characteristics. 6Dr. Finkelstein also pointed out that nanomaterials will not only lead to human exposure,but can be dispersed in the environment and could be toxic to ecosystems (Figure 3). Heagreed that nanoparticles have been around in nature for a long time, but with our currentability to engineer them for specific purposes, he stressed that measuring and assessing theirenvironmental distribution become even more important.Box 3. Standard human-health risk assessment paradigm for chemicalsSource: National Research Council. Risk Assessment in the Federal Government: Managing theProcess (1983).Step 1: Hazard IdentificationStep 2: Dose-Response AssessmentStep 3: Exposure AssessmentStep 4: Risk Characterization6Oberdörster, G. et al. “Principles for characterizing the potential human health effects from exposure tonanomaterials: elements of a screening strategy.” Particle and Fibre Toxicology 2:8 (2005).13

Figure 2. Uptake and distribution of nanoparticles in an organismSource: Oberdörster et al. Environmental Health Perspectives 113:823-839 (2005); J.Finkelstein, presentation, September 15, 2005.Figure 3. Environmental pathways and potential exposure routesSource: Oberdörster et al. Environmental Health Perspectives 113:823-839 (2005). J.Finkelstein, presentation, Sept 15, 2005.14

Governance FrameworksGovernance systems are currently in place for a variety of products associated withnew technologies. For the design of oversight models for nanotechnology, there areopportunities to learn from past experiences with other technologies and products, andit is important not to recreate what already exists. Some argue that nanotechnology isalready suitably covered by existing regulatory and non-regulatory oversight activities,whereas others disagree, arguing that many products on the market are falling throughthe cracks of a system that has not been formalized or coordinated. As a society, we havechoices of creating new laws and/or regulations, revising existing ones, interpreting existingones to cover nanoproducts, designing non-regulatory approaches, or modifying existingnon-regulatory approaches. The diversity of the products at the nano-bio interface mightpreclude a single approach or framework, as one size might not fit all (Table 2).One particular example of oversight from which lessons could be learned is theCoordinated Framework for the Regulation of Biotechnology. 7 In this case, a governanceapproach was developed for the products of biotechnology by using a patchwork ofexisting laws. EPA, the Food and Drug Administration (FDA), and the US Departmentof Agriculture were identified as lead agencies for specific products (Table 3). Underlyingprinciples of the framework were that the products, not the process of biotechnology,should be the focus of regulation and that genetically engineered organisms (GEOs) arenot fundamentally different from non-engineered organisms. Therefore, existing laws weredetermined to be sufficient. After the framework was published, the agencies chose pathsto develop regulations under existing laws or provide guidance and policies under them.This approach and others should be closely examined for their relevance to the products ofnanotechnology.This session of the workshop examined oversight systems for the nano-bio interface. It alsoconsidered appropriate features of governance systems for ensuring public confidence andsafety.7Office of Science and Technology Policy. Coordinated Framework for the Regulation ofBiotechnology. 51 Fed Reg 23302 (1986).15

Table 2. A few examples of products of nanotechnology applied to health,food, or the environment(Note: this is not a complete list)Source: J. Kuzma, compiled from company web searches; many examples from the list wereinitially provided by N. Savage, EPA.Company Product Purpose/Method StageHealth/MedicineAmerican Bioscience, Inc.(ABI)Abraxane ®Nanoparticulateformulation of thewidely used anticancerdrug paclitaxel formetastatic breastcancer. First approvalof protein albuminnanoparticles as a“natural solvent.”Received final FDA approval inJan. 2005.BioSantePharmaceuticalsBioVant,BioOral,BioAirCalcium phosphatebased(CAP)nanotechnology fororal, nasal, and transcutaneous routes ofdelivery of vaccinesand proteins.GP Surgical TiMESH Hernia mesh madewith titanium nanocoating.Health PlusInternational, Inc.Spray ForLife®,VitaminB12 EnergyBoosterNanoceuticalDelivery System(NDS), dispersesactive molecules intonanodroplets, increasesbioavailability ofnutrients or drugs.StarPharma VivaGel Polyvalent, polylysinedendrimer as the activeingredient. Intended toprevent transmissionof sexually transmitteddiseases (STDs).Environment/HealthEnviroSystems EcoTru® Nanoemulsiontechnology to disinfectsurfaces for bacteriaand viruses.CAP is in preclinical safety trials,as indicated by the companywebsite.FDA approved, implanted device;commercially available.Commerically available, but notFDA approved.Determined to be safe and welltoleratedin Phase 1 clinicaltrials as an Investigational NewDrug (IND) under FDA (2004),according to the companywebsite.Commercially available.Severn Trent Services &Bayer AGSORB 33®Bayoxide®E33Nano-sized surfacestructures that areable to absorb arsenic;composed of ferricoxide.Certified for drinking watersystems by American NationalStandards Institute/NSF Standard61. FDA pre-market reviewwould be required under theFederal Food Drug and CosmeticAct (FFDCA) if used in bottledwater.16

Food/HealthbioMerieux FoodExpert-ID® High-throughput genechip for testing foodand animal feed fortraceability and safety.In trials in some Europeancountries (2004).NanocorVariety ofproducts underthe Nanomer®trademarkNanoclays andcomposites providingbarriers to oxygen andcarbon dioxide flowused in food packagingto keep freshness andblock out smells.Nanomer® nanoclays areavailable for commercialuse. Infrastructure in placeto produce more than 100million pounds annually.NanoplexTechnologiesNanobarcodes®ParticlesEncodeable, machinereadable,durable,metallic rods. Particlesare intrinsicallyencoded by virtueof the difference inreflectivity of adjacentmetal stripes. Used forsupply-chain trackingfor food.Product expected on marketin 2006.NutraLeaseShemen IndustriesLtdCanola ActiveNanocapsules incooking oil to improvebioavailability ofnutraceuticals, forexample, plantsterols to reduce thebody’s absorptionof cholesterol in theblood.On market in Israel; FDAhas not reviewed thisproduct. Sponsor websiteindicates “Canola Active- complies with FDArequirements.”OilFresh OilFresh TM Vertical insert, madeof an advancednanoceramic material.For use in cooking oilfor better quality.Samsung Nano SilverSeal Nano-silver compoundin the product designto suppress thespread of bacteriaand other microbes inrefrigerators.Sponsor website indicates“OilFresh is authorizedby the FDA.” However, asmaterial is not expectedto migrate into food, FDApre-market review was notrequired.Commercially available.17

Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C., Washington,DC, spoke about EPA activities pertinent to nanotechnology and the challenges facingthe agency. EPA is a large organization committed to protecting human health and theenvironment, and it has many important responsibilities and priorities. However, its budgethas been flat or decreasing in recent years, and its diminished resources pose difficultchallenges for prioritizing activities. Ms. Bergeson posed the question of how EPA can useits statutory authority and develop capacity to review scientific and technical informationabout nanotechnology under such resource constraints. There already are products incommerce (Table 2), so the problem is particularly important now. Despite the challenges,EPA is harnessing its abilities to provide guidance on the scope of its regulatory authorityand devoting its limited resources to considering how best to reap the benefits and identifyand control the risks of nanotechnology. Ms. Bergeson provided examples of EPA activitiesin these areas.EPA convened its Science Advisory Board (SAB) in December 2004 to considernanotechnology and other emerging technologies. The SAB is the main external expertbody that provides advice to the EPA on scientific and science policy matters. It concludedthat nanotechnology can provide great benefits, but nanomaterials require additionalinvestigations of environmental, health, and social impacts. SAB members noted thatadvancements in new technologies are occurring at unprecedented rates, making it difficultfor government agencies to keep abreast of emerging developments. The SAB suggestedthat additional skill sets may be needed at the agency in order to develop new approaches(e.g., toxicological) for nanomaterials. Ms. Bergeson stated that the good news is that thereis broad recognition at the very highest levels of EPA that nanotechnology needs attention;but the bad news is that since the SAB meeting, EPA has not been able to progress inresolving many of the difficult issues the SAB identified in 2004.In another example, Ms. Bergeson described EPA’s consideration of a voluntary reportingprogram under the Toxic Substances Control Act (TSCA) for the review of existingnanomaterials. Chemical substances are currently regulated under TSCA, which wasenacted in 1976. However, Congress did not necessarily envision that this statute wouldbe used to manage the risks and benefits from nanomaterials. Ms. Bergeson indicated thatamending TSCA is unlikely in the short term, and perhaps even in the long term. Therefore,creative ways are needed to ensure that nanoscale materials are addressed appropriatelyunder existing legal authorities. EPA believes that TSCA is sufficiently elastic to addressnanoscale materials and has requested on several occasions, comment on the feasibility of avoluntary program. The agency has also urged stakeholders to come together to discuss thefeatures of such a program. Ms. Bergeson noted that in general, there is broad support fora voluntary reporting program as a starting point, but that the difficulty lies in developingthe details of this type of program.The National Pollution Prevention and Toxics Advisory Committee (NPPTAC) was formedunder the auspices of the Federal Advisory Committee Act to provide guidance to EPA onTSCA implementation and related EPA toxics programs. The NPPTAC recently agreedto form an ad hoc interim work group on nanoscale materials to provide guidance on18

the prudence and scope of a voluntary reporting program on nanoscale materials. TheNanoscale Materials Voluntary Program (NVP) was agreed upon in concept during theNPPTAC ad hoc interim work group discussions convened through the summer of 2005,which progressed and concluded in the fall of 2005. The work group was charged withtaking public input and issues into consideration and assessing the possible review ofnanoscale materials under TSCA. The recent NPPTAC work group report describes theNVP as follows: 8The NVP is intended to encompass engineered nanoscale materials now in or soonto enter commerce and the approaches under the NVP are intended to be availableto both “new” and “existing” chemical nanoscale materials, regardless of whetherthey would otherwise qualify for various exemptions, or fall below reporting ornotification thresholds, now applicable under TSCA provisions. This scope wouldapply without prejudice as to whether such distinctions, exemptions, or thresholdsdo or should apply in other contexts beyond the duration of a voluntary program.Participation in the NVP does not supersede, rather it complements, the newchemical notification requirements for new chemical nanoscale materials.In this context “soon to enter commerce” is defined as applying to pre-commercialnew and existing chemical engineered nanoscale materials for which there is clearcommercial intent on the part of the developer, excluding such materials that areonly at the research stage, or for which commercial application is more speculativeor uncertain.Details of the NVP for which agreement will be difficult include, among others, definingthe scope (e.g., should it review emerging chemicals, or only those now in commerce),deciding whether data generation should be part of the program, balancing transparencywith protecting confidential business information, and including a diverse number of smalland medium sized enterprises. The NPPTAC transmitted to EPA Administrator Stephen L.Johnson its “Overview of Issues for Consideration by NPPTAC” on November 22, 2005. 8The document offers the NPPTAC’s analysis and views of a framework for a voluntaryprogram for engineered nanoscale materials, a complementary approach to new chemicalsnanoscale requirements under TSCA, and other relevant issues.In addition to the above activities, EPA’s Science Policy Council (SPC) developed a whitepaper on nanotechnology that will have cross-program implications for the agency. Thepaper reviews science deficits and data needs for the agency and guides programmaticelements for both applications and implications of nanotechnology. The draft of the whitepaper was released to the public for comment in December 2005. 98EPA. Overview of Issues for Consideration by NPPTAC. Available at http://www.epa.gov/oppt/npptac/pubs/nanowgoverviewdocument20051109.pdf (2005).9EPA. External Review Draft Nanotechnology White Paper Prepared for the U.S. Environmental ProtectionAgency by members of the Nanotechnology Workgroup, a group of EPA’s Science Policy Council. Available athttp://www.epa.gov/osa/nanotech.htm (2005).19

Ms. Bergeson concluded that there is currently little interface between nanotechnology,biotechnology, information technology, and other emerging and converging technologieswithin EPA, because the agency lacks adequate time and resources to consider thesematters. This interface is critically important, and EPA recognizes the need in this area.Ms. Bergeson expressed her belief that EPA lacks the resources necessary to progressexpeditiously with the regulation of products of nanotechnology in a way that will ensurepublic confidence and that voluntary, collaborative efforts are essential to fill this void.The challenges for EPA are to stay on top of program priorities set years in advance,while responding to crises (e.g., Hurricane Katrina and other natural disasters affectinghuman health and the environment) and anticipating and managing emerging technologies,including nanotechnology. Training, recruitment, and infrastructure development wereidentified by the SAB as key priorities for EPA to meet these challenges.Table 3. Coordinated framework for the regulation of biotechnologySource: National Research Council. Genetically Engineered Pest-Protected Plants: Scienceand Regulation (2000).Agency Jurisdiction LawsUS Dept. ofPlant pests, plants, Federal Plant Pest ActAgriculture (USDA) veterinary biologics (FPPA)Food and DrugAdministration(FDA)Food, feed, food additives,vet drugs, human drugs,human biologicals, medicaldevicesFederal Food, Drug andCosmetic Act (FFDCA)Environmental ProtectionAgency(EPA)Microbial and plantpesticides; novel microbesFederal Insecticide,Fungicide, andRodenticide Act(FIFRA); FFDCA; ToxicSubstances Control Act(TSCA)20

Norris Alderson, Associate Commissioner of Science at FDA, described FDA activities atthe nano-bio interface. He stated that FDA’s approach to nanotechnology is no differentthan its approach to any other technology, as the agency regulates on a product by productbasis. It does not regulate technologies, but regulates several kinds of products (Box 4)in basically three ways. Drugs are regulated via a pre-market approval process, and theyhave to pass safety, efficacy, and manufacturing standards. Devices that are of low riskare regulated on the basis of “acceptance of the product.” They are expected to meet preapprovedstandards (category 510ks), and if these are met, marketing can begin. Cosmeticproducts can be marketed without any type of evaluation or review. Dr. Alderson stressedthat FDA processes are not static, and as the agency learns more, it evolves its reviewmethods. FDA also provides assistance to industry to bring products to the marketplace. Inaddition to its regulatory activities, FDA oversees research on the products it regulates.Safety considerations for FDA include access of nanomaterials to cells and tissues, timein the cells and tissues, clearance of the materials in cells and tissues, and effects on celland tissue function. Absorption, distribution, metabolism and excretion (ADME) arekey issues. Extensive preclinical tests, involving pharmacology, toxicology, geno-toxicity,developmental toxicity, immunotoxicity, and carcinogenicity, are required for safetyevaluations. Features of tests include the use of high dose multiples, at least two animalspecies, histopathology on most organs, and extended dosing periods. However, FDA doesnot conduct these safety tests themselves, but rather the drug sponsor develops them. Theagency provides guidance and direction for the tests and evaluates them after they areconducted. It considers not only safety, but also pre-clinical medical utility for products andmanufacturing standards for a consistent and quality product.Another important issue for FDA is nanomaterial release into and impacts on theenvironment following human and animal excretion. Dr. Alderson questioned whether theagency has the information and correct methodology to determine the nature of releaseand quantify nanoparticles in the environment. The agency also needs more informationon the forms of nanoparticles that are presented to cells, standardized procedures to detectparticles in cells, stability and critical and physical properties of nanomaterials, and theeffects of scale-up and manufacturing on the characteristics of nanomaterials. Dr. Aldersonstated that in general, the FDA believes that existing toxicological tests are adequate formost nano-products. The agency will continue to proceed in that manner until it sees aneed for a change.Dr. Alderson described several regulatory issues for the agency. One is the regulation of“combination products.” These typically span different centers at FDA, each having aseparate review process. Many more combination products are coming down the pipeline,and challenges in coordinating their review will need to be met. Another issue is the factthat FDA can only regulate products based on the claims of the sponsor. Ultimately, FDAmay be unaware that nanotechnology is being used in a particular product. Furthermore,FDA has only limited authority for potentially high risk nano-products, such as cosmetics.He cited key challenges: preparing for “unknown” risks, dealing with them, and adoptingnew procedures for doing so; communicating with manufacturers of new medical products;involving stakeholders; communicating risks to the public; and reporting relevant scientificfindings in a timely fashion.21

Box 4. FDA regulated productsSource: N. Alderson, presentation, September 15, 2005.• Foods– All interstate domestic and imported, including produce, fish,shellfish, shell eggs, milk (not meat or poultry)– Bottled water– Wine (

Evan Michelson, Research Associate from the Project on Emerging Nanotechnologies,Woodrow Wilson International Center for Scholars, described other types of issues ingovernance systems, including risk perception (e.g., what the public sees with regard tonanotechnology and how it responds) and structural risks (e.g., how nanotechnologyaffects the structure of industry). He stated that there is not enough work being done inthese areas or on ecological risks. For example, he noted that globally, there are at least27 firms producing carbon nanotubes, with 108 metric tons produced in 2004 and 1000metric tons projected for 2009. However, there has been little attention paid to end-of-lifeissues such as incineration, land-filling, and recycling.Mr. Michelson stressed that both the public and industry are concerned about controllingnanotechnology, managing the risks, and considering potential gaps in regulation.Workers in industry and students in academic labs are primarily the ones who are exposedto nanoparticles right now, especially in developing countries where infrastructureand training for health and environmental safety are lacking. In the case of carbonnanotubes, he indicated that production is shifting to Korea and China, yet both in theU.S. and abroad, there is no agreed upon guidance in terms of worker safety practicesfor nanomaterials. He noted that regulatory guidance is particularly important for smallbusinesses which often do not have the resources to devote to environmental health andsafety.Risks will change and shift as nanotechnology does. For example, we are currently movingfrom passive nanostructures to active nanostructures, such as those at the nano-biointerface (Figure 4). Mr. Michelson argued that our state of understanding about risk is inthe past and as the technology moves forward, people will only accept risks if big benefitsoccur. However, many are worried that the big benefits, such as cancer treatment or cheapand clean energy, will not materialize if regulations are not in-step with advances and amishap occurs as a result. He stated that with a growing number of nano-based productsout on the market, the federal oversight process will increasingly have trouble keeping upwith the pace of product development and market entry, as it can take several years to fundand conduct research on the health and environmental risks, and even longer to amend orformulate regulations.23

Figure 4. Projected movement of nanotechnology.Source: E. Michelson presentation, September 15, 2005; timeline adapted from M. Roco, NSF.ActiveNanostructuresTransistorsTargeted drugsSystems ofActuatorsPassiveNanosystemsAdaptiveNanostructuresstructuresRoboticsCoatings,3D networkspolymersGuidedceramicsassemblersMolecularNanosystemsMolecules bydesignEvolutionarysystems2001 2005 2010 2020Disruptive changesaffecting risk assessmentNano-BioInterfaceQuantum/classicalphysics interfaceSelf-directed,emergent behaviorsOur state ofunderstandingFigure 5. Current regulatory system in the U.S. in the context of nanoproductsSource: E. Michelson presentation, September 15, 2005.Consumer ProductsChemical/ParticlesManufacturingDevicesDrugs/biologicsCosmeticsFoodAgricultural24

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Mr. Michelson stressed that it is important to consider both the current and potentialcracks in the regulatory system, as well as the general approach that we, as a society, wantto take towards regulation. He indicated that some products, such as cosmetics, makeit through the system today without any required safety review (Figure 5, page 24). Forsome substances, like drugs, there is comprehensive safety review, and other productsfall in between these two extremes. He also identified a range of potential approaches tothe regulation of nanomaterials, from more restrictive, like a moratorium on use or thetreatment of nanomaterials as new substances, to more permissive, like voluntary standardsand guidelines or no special state of regulation. Mr. Michelson discussed an examplewhere proactive regulation, in the form of a city ordinance for use of recombinant DNA inCambridge MA in 1976, was one of the factors that led Biogen to move its headquarters tothat area. Public aspects of transparency, good governance, and a mature understanding ofthe field made the location attractive for business.He concluded with several important questions about oversight at the nano-bio interface(Box 5), including whether the federal agencies have the authority to appropriately regulatenanotechnology, whether the political will exists to do so, and whether the agencies havethe resources to do so, even with the authority and will.26

Box 5. Key questions about nano-bio governanceSource: E. Michelson, presentation, September 15, 2005.• Whom does the public trust to manage the risks posed by nanotechnology?• Has risk information been communicated and made available to the public?• Are public perceptions being included and used to inform debates aboutproposed and pending regulation? What mechanisms work best to regulatenanotechnology-based products?• Have potential long-term risks, issues, and consequences been analyzed? If so,by whom and how?• How have uncertainties and “domains of ignorance” been taken into accountduring the decision-making, policy-making, and standard-setting process?• Who will be responsible, and who will be held accountable, for any unforeseenharm, ill-use, or dangerous applications of nanotechnology?• Do EPA, OSHA, USDA, etc. have the authority to regulate nanotechnology?• Does the political will exist to implement that authority?• Do the agencies have the resources (e.g., money, people, expertise, etc.), even ifauthority and will exist?27

Alan Ziegler, Member of the Board of Directors of the Converging Technologies BarAssociation (CTBA), discussed a non-regulatory scheme for governance that combines tortlaw and insurance to reduce social costs and harm, and how this scheme could be used forthe products of nanotechnology. The primary function of tort law is to remedy harm orcompensate victims, while that of insurance is to spread risk. However, both also createincentives to reduce accidents in business operations and affect the pace of change andinnovation in society.Specifically, he discussed the concept of enterprise liability and two theories under it. Onetheory is that it is fair to put the burden of action on those who have ability to pay andspread the risk (i.e., fairness rationale). The other theory is based on the notion that ifpotential injurers know they will be held liable for harm, they will take appropriate actionsto reduce harm (i.e., economic rationale). In some cases, a defect in manufacturing, design,or warning is necessary for product liability. However, in other cases, an injury traceableto the product used in its normal way may be enough for liability. Recently, there has beena tidal wave of litigation for medical products. In some cases, this stifles innovation indevelopment of useful products. For example, a drug that works great 99.8% of the timeand leads to serious harm 0.2% of the time could potentially cost developers billions ofdollars in lawsuits, much more than profits from the sale of it. Nano-bio products face thisclimate of liability and litigation.Insurance can provide some protection to developers, but there are issues that reduce itseffectiveness. Moral hazard is a theory in which developers that have insurance may changetheir behavior and engage in more risky actions. Also, as uncertainty in risk increases,premium costs rise to the level where coverage effectively is not available for valuablesocietal activities. Mr. Ziegler gave the example of insurance for vaccine developers. In the1970s, costs of the insurance on the DTP vaccine for children rose 2000%, and 96% ofthat rise was due to product litigation. Due to cost, insurance essentially was not availableto developers. Insurers have the ability to set safety standards for those they insure, andlower premiums if standards are met. In this sense, they are helping to manage risks inindustry. If the developer does not comply, the insurance policy costs could increase or thepolicy could be cancelled.Many believe that the greatest benefits of the nano-bio interface will come in medicineand pharmaceuticals, but Mr. Ziegler raised concerns that current insurance practiceswill not be able to cope with coming changes in nanoproducts, as they will be toorevolutionary, widespread, and rapid. High litigation and lack of affordable insurancecould deter research and development, or if development occurs, products may onlybe affordable for very few. He described ways of dealing with this issue. For example,government could absorb the costs as the defendant, statutory caps could be placed oncompensation for harm, government could indemnify victims, or statutory restrictionscould be placed on lawsuits. He proposes that we need statutory change if we are to reapthe benefits of nanotechnology: we need to tighten regulations so mishaps do not occur;insulate manufacturers if they follow tight regulations; and create selected compensationfunds. These actions would remove substantial obstacles to realizing the promise ofnanotechnology.28

Striking a BalanceSociety is both a supporter and watchdog of new technologies, and it strikes a balancebetween allowing technology to flourish and limiting it to acceptable use. Organizationsplay multiple roles, sometimes both promoting technology while ensuring its safety. Thesocietal context for the nano-bio interface includes social, economic, institutional, political,and ethical issues and is not limited to technical risk or regulatory authority. In the past,there have been tendencies in scientific communities to argue for governance based solelyon “sound science.” Yet, science alone cannot determine what level of risk is acceptable,and factors involved in risk analysis vary among regulatory agencies. Risk managersconsider other factors, including social ones, before making decisions. Decisions are seldombased solely on science, especially when significant scientific uncertainty exists. Societalcontexts come into play in setting the scope of technical risk assessments and interpretingtheir relevance for communities. 10 In this model, the public is not just the recipient of riskcommunication, but actively involved in all facets of risk analysis and decision making. Inthe third session of the workshop, questions of oversight were expanded from technicalrisks and benefits of nanoparticles and regulatory frameworks and authorities, to societalcontexts that interpret and affect nano-bio applications.First and foremost, there is a need to understand public viewpoints on nanotechnology andlearn more about its context from the perspective of non-experts. Jane Macoubrie, SeniorVisiting Scholar at the Woodrow Wilson International Center for Scholars, spoke abouther work on public perception of nanotechnology and trust in government. In two separatesurveys in 2004, she found that 95% of respondents did not trust government or industryto effectively manage the risks associated with nanotechnology. 11 In experimental issuegroups where people were given information on nanotechnology, she found that medicaland general industrial applications for nanotechnology generated lower trust and thathigher education levels of participants predicted lower trust. People’s basis of concern wasgenerally experience, or a “history of failed precautions.” However, at the same time, herstudies found that people are excited about the benefits and the knowledge to be gainedthrough nanotechnology.In 2005, Dr. Macoubrie conducted another study to address why there is such low trustin government and industry, what people want that would increase trust, and wherepeople are presently getting information about nanotechnology. 12 The work also addressedwhether trust was relative to specific regulatory agencies or parts of government, why therewas such low trust in medical and industrial applications, and whether new information onnano-bio convergence would have influence on trust. In this study, she found that peoplegenerally do not have knowledge of nanotechnology, but once given information, they have10National Research Council. Understanding Risk (1996).11Cobb, M. and Macoubrie, J. Public perceptions about nanotechnology: risks, benefits and trust. Journal ofNanoparticle Research 6: 395-405 (2004).12Macoubrie, J. Pew Charitable Trusts Project on Emerging Nanotechnologies, Woodrow Wilson InternationalCenter for Scholars, Informed Public Perceptions of Nanotechnology and Trust in Government, September (2005).29

neutral or positive attitudes about it. She also found that people tend to get informationabout nanotechnology primarily from public television and radio, word of mouth, ormagazines. In her study, there was increased trust in some agencies after learning aboutnanotechnology, but less in others. Before and after learning, participants trusted Congressand the White House the least, and after learning, participants lost trust in FDA and USDA.Top categories of concern among the participants were “true unknowns”(13%), regulation(13%), human health risks (13%), testing and research for safety (12%), and effect on theenvironment (10%).The study groups recommended the following for restoring public trust: better and moretesting to discover risks; engaging the public and providing information; and adoptingmandatory standards. Group participants generally thought that voluntary standards arenot enough. However, 76% said that a ban on nanotechnology would be over reacting. Dr.Macoubrie emphasized that the public has a particular perspective, one that industry andregulators should consider. She argued that for nanotechnology, we do not want to spendbillions of dollars and end up with an industry that lacks the confidence of consumers andis not viable.Robert Hoerr, Cofounder, Chairman, and CEO of Nanocopoeia, Inc., presented thesmall company perspective. His company is very much aware of the importance of publicperception and the value of proceding with caution. It developed the ElectroNanoSpray TMnanoparticle generator for use in creating suspensions of particles for gene delivery, drugformulation, device coating, and other applications. Researchers at his company arepositioned amidst the convergence of drugs, devices, and nanotechnology, and Dr. Hoerrraised the concern that what they are doing might not fit nicely into the classic regulatoryparadigm.He pointed out that the same things that make nano-drugs attractive also present specialconcerns (Table 4). These concerns need to be kept in mind when a process is developed,and each compound and opportunity should be carefully reviewed. He also stated thatnanotechnology presents unique risk characteristics, which are often unknown when workwith the materials begins. Additionally, there is almost no one to turn to for help withrisk information. For example, it is not clear what gloves or masks do to limit exposureto nanoparticles. Yet to reduce risk to workers, industry needs to control exposure. Hiscompany follows that principle in its laboratories. They use common sense, adherence togood manufacturing principles, and safe material handling procedures. Dr. Hoerr agreedthat all stakeholders need to be involved in risk assessment and that future regulationshould be data-driven and cost manageable. However, he argued that fear should not drivethe process, as heavy regulatory burdens could have profound effects on small companies.Paul Thompson, Professor of Philosophy and W.K. Kellogg Chair in Agricultural, Food,and Community Ethics at Michigan State University, discussed two topics related tonanotechnology used in agriculture and food: power relationships and changes in ruralcommunities. He made the point that mobilization of groups will occur due to continuedfailure to address social and ethical issues surrounding technology. One social issue involves30

power relations in the food system, which extends from suppliers to farmers; to processing,distribution and marketing in industries; and finally to consumers. Retailers and consumershaven’t typically been engaged in what is happening in early stages. Important factorsfor them have been price and quality, as they are visible and testable. However, recently,there have been changes in this paradigm. For example, retailers are increasingly interestedin upstream processes for inventory control and product standards (e.g., grocery chainsrefusing to sell genetically modified foods), and consumers are starting to show interest inupstream processing (e.g., organic farming, animal treatment).Dr. Thompson noted that these broad changes are in a sense technology-driven, but theyare also affected by regulatory processes. Currently, regulation is based on the end-productand health and safety standards. He questioned what role regulation will take as we see ashift in consumer interest towards the supply chain. There will be a need to balance marketpower with protecting consumer rights to know and choose. He posed the question ofwhether consumers should have legal rights with respect to the food system. Early in thesupply chain, process standards might not be wanted. For example, farmers might not wantconsumers telling them to not use genetically modified seed. Dr. Thompson suggested thatquestions of power and rights are too deep for scientists to handle alone.There is evidence that technology has changed the structure of agriculture. 13 There arefewer and larger farms, and there is evidence for decline in rural communities as a result.Dr. Thompson noted that agricultural biotechnology was debated in this context, andas a result, there is dissatisfaction with it. Non-governmental organizations (NGOs) andcommunity groups have pushed to influence directions for agricultural research that moredirectly serve the public. However, they have largely been unheard, and therefore, suchgroups have shifted focus to where they can challenge what is occurring, for example,through litigation and regulatory challenges. He asked whether concerns about thestructure of industry, consumer choice, and ultimately, what is in the best interest of thepublic, are on the trade-off agenda for agrifood nanotechnology.Karen Florini, Senior Attorney at Environmental Defense (ED), evaluated currentregulatory activities for nanotechnology that affect public perception of safety. ED isoptimistic about nanotechnology’s promise for the environment--for cleaner or renewableenergy, more efficient lighting, water filtration, and lightweighting of materials. However,the organization is concerned about the toxicity of engineered nanomaterials. In 1998,ED worked in collaboration with the American Chemistry Council and EPA to create aprogram under which chemical producers agreed to generate screening-level toxicity datafor high production volume (HPV) chemicals. This program illustrated that voluntaryinitiatives can play a useful role under certain circumstances in addressing environmentalconcerns. The HPV challenge was prompted in part by an ED study showing that 71% of apilot group of HPV chemicals lacked basic screening for toxicity, at least from what couldbe determined from the public record. Ms. Florini argued that more extensive informationshould be available for nanomaterials in light of the novel properties that they may exhibit.13National Research Council. Publicly Funded Agricultural Research and the Changing Structure of U.S.Agriculture (2002).31

With other chemicals, ED has seen significant problems arise with government oversight,liability, and public perception. Ms. Florini posed the question of how we can getnanotechnology right this time. She summarized four key steps: increase risk researchfunding by government and industry, develop effective regulations, introduce voluntaryinterim standards, and conduct meaningful stakeholder engagement. She noted that it isdifficult to tease out exactly how much money is spent on risk implications research, ascurrent statistics often mix those funds with those for applications of nanotechnology.Her group believes that much more should be spent on research to assess the risk ofnanomaterials.Ms. Florini listed potential regulatory avenues, or statutes that could apply to the productsof nanotechnology. However, she said that there is skepticism in the environmental lawcommunity about whether those statutes, with the exception of FFDCA and TSCA, willbe used for nanomaterials in the near to medium term. With respect to TSCA, there area number of critical issues as to whether the statute will be able to accomplish anything.For example, there are important questions about which nanoparticles are new chemicalsunder TSCA, and thus triggered for the Pre-Market Notification (PMN) program; whatdata are needed for PMN reviews; and whether current PMN exemptions make sense. NNIdefines nanotechnology as creating and using structures that have novel properties, yetunder TSCA, some nanomaterials might not be considered new, as the molecular structureor formula might be the same. Her proposal is that an engineered nanomaterial should beconsidered new regardless of whether its molecular structure of formula is new, unless itschemical and physical properties are demonstrably the same as its conventional analog.Ms. Florini also noted that there are currently no baseline data requirements underPMN. Developers are required to submit the chemical’s identity and modest additionalinformation. If developers have toxicity data, they must submit it, but they are not requiredto generate it unless EPA asks them specifically to do so. She and others at ED believe thatEPA should provide nanomaterial producers with guidance on data that should be includedwith a PMN, such as basic information on chemical characteristics, environmental fate andtransport, and toxicity. Finally, she emphasized the importance of stakeholder involvementin the design of oversight systems, including people from civil society, labor, industry, andacademe.Davis Baird, Professor of Philosophy at the University of South Carolina, spoke abouthis work on the societal, epistemological, and ethical dimensions of nanotechnology.He indicated that as a society, we need to understand nanotechnology from the inside.Nanotechnology should not be put in a “black box” and thought of as having “impacts”on society. Instead, we should open up the box and study the “interactions” betweensocial and ethical practices and creating knowledge at the nanoscale. He stressed thatunderstanding and directing these interactions will require understanding the practices ofknowledge production and dissemination. This understanding can only be achieved bybringing multiple disciplines into fruitful exchange. However, Dr. Baird pointed out thatthere are barriers in universities to multidisciplinary research, such as reward and tenuresystems.32

Communication about nanotechnology will impact how the public views nanotechnologyand affects the governance of it. As one example, Dr. Baird’s group is working on hownanotechnology is portrayed visually to the public. In some instances, visual images ofnanotechnology look very familiar (e.g., IBM logo written at the nanoscale). However, thereal “nanoworld” might look very different (e.g., filled with motion and collision). Imagesare very important, and his group is investigating what it takes to better understand anduse images of the nanoscale.Table 4. An example of balance: the promise and pitfalls of drugnanoparticlesSource: R. Hoerr, presentation, September 15, 2005.PromiseIncreased surface areaIncreased bioavailabilityLower doses effectiveSkin and membrane penetration may speedonset of actionPitfallsIncreased reactivity?Increased toxicity?Lower doses toxic?Toxicity through nontraditional routes ofadministration?33

The FutureThe final session of the workshop addressed the need to look toward and consider farfutureapplications of nanotechnology in the design of oversight systems. For example,some are now concerned that the 1986 Coordinated Framework for the Regulation ofBiotechnology was not designed for the present diversity of biotechnology productsand that existing laws are being twisted in strange ways (e.g., genetically engineeredanimals are proposed to be regulated as new animal drugs under FDA). The developersof the coordinated framework did not necessarily envision the types of products now indevelopment.Christine Peterson, Vice President of the Foresight Nanotech Institute, described mid- andlonger-term time frames for the future. In the mid-term, five years and beyond, more activenanostructures will be developed, such as sensors, actuators, and targeted drugs. Sheargued that it is difficult to get information in this time frame, as it is beyond most businesstime frames, and academics do not like to speculate. The military is paying attention to it,and important economic and strategic changes accompany its evolution.In the longer term, molecular nanosystems, not just materials or single devices, willemerge. The boundaries for this era will be limited only by what is physically or chemicallypossible. Longer term goals for the use of nanotechnology might also include morecomplete control of the structure of matter, making materials atomically precise, anddesigning molecular machines to do work. With these future applications, additionalgovernance issues arise. Health and environmental safety issues will still be around,however, concerns about privacy and surveillance will increase, as well as the use ofnanotechnology for terrorism.Applications to human enhancement will present society with fundamental social andethical issues. Nanotechnology could someday be used to improve senses, memory,strength, and beauty; delay or even stop aging; or control emotion and personality. Ms.Peterson posed the question of whether these applications should be illegal and raised thepoint that in an international context, they are unlikely to be illegal everywhere. Differencesin international governance could create inequalities, as only people who can afford totravel and pay for such enhancements will benefit. Furthermore, there will be culturaldifferences in acceptance of these applications, and values of various societies need to berespected.Her organization is developing guidelines for safer development of nanotechnology, 14which are designed to address the potential positive and negative consequences in an openand scientifically accurate matter. The objective of the guidelines is to provide a basisfor informed policy decisions by citizens and governments. Specific guidelines for theresponsible development of nanotechnology-based productive nanosystems are included. 15Ms. Peterson views voluntary guidelines as the first step, although they are not enough. Shechallenges those who say certain applications are impossible, remembering when many saidthat about the internet and mammalian cloning, and argued that we need to stretch ourminds in thinking about the future.14Foresight Nanotech Institute. Foresight Guidelines Version 4.0: Self Assessment Scorecards for SaferDevelopment of Nanotechnology by N. Jacobstein and G. H. Reynolds Version 4.0: http://www.foresight.org/guidelines/current.html (2004).15http://www.foresight.org/guidelines/current.html34

Richard H. Smith, President of the Nanotechnology Network Principal, focused ongovernance of nanotechnology from an investment perspective. He discussed the needfor a paradigm shift from doing “normal science,” in the definition of Thomas Kuhn,or “business as usual,” to investing heavily in nanotechnology to solve great societalproblems. He made the point that we are currently investing about $1 billion a year innanotechnology, but we make much larger investments in science that is not as groundbreaking. For example, we invest $35 billion in NIH, where projects generally need to besure bets. He gave the example that we are spending a lot of resources to recover fromHurricane Katrina (approximately $500 M a day in September 2005), yet nanotechnologycould be used to prevent disasters such as this one, or to recover from them. He argued thatbig investments in nanoapplications will pay off in the long run and recommended that webegin to invest in long-term, problem-focused nanoscience.Sheldon Friedlander, Parsons Professor of Chemical Engineering at UCLA, described theparallels between aerosol science and nanoscience, and how the body of techniques andunderstanding from aerosol science could be used in the future for nanotechnology. Aerosoltechnology has a large domain, spanning particle diameters from 10 -3 to 10 2 µm (0.1 to100000 nm) (Figure 6). There are aerosol and nanoparticles in the atmosphere, eithernaturally occurring, or from diesel emissions or industrial processes.The aerosol system provides a useful example for developing powerful methodology.The aerosol industry has had many years of experience in data collection, including thatfor worker exposure. With aerosol technology, particles can be made as spherical dropletsor aggregates and with specific side chains, and there is a good understanding about howaerosols form. Nanotechnology is a huge field, covering films, surfaces, liquids, and gases,and developing methodology for study of the environmental and health effects is hard to doas a result. Dr. Friedlander suggested that it would be beneficial to select focused systemsthat are well-established in order to better understand nanoscience and its applications.35

Figure 6. Domains of aerosol technologySource: S. Friedlander, presentation, September 15, 2005.36

ConclusionsThe following conclusions reflect themes that emerged from the workshop, however,given the diversity of participants (Appendix), not all of them necessarily agree with eachparticular one.Defining NanotechnologyParticipants at the workshop disagreed to some extent on the importance of definingnanotechnology and its applications to biology. Some argued that definitions matterbecause we need to attribute benefits and pitfalls to nanotechnology, and they may benecessary with respect to governance under legal statutes and regulations. However, thenanotechnology-biology interface is broad, and many believe that we should be thinkingabout governance more broadly. Because there are so many diverse applications, it isimportant to distinguish between agricultural, industrial, and medical applications, as thereare different regulatory and marketing implications, as well as different public perceptionand acceptance landscapes.Participants questioned whether there will be a different set of requirements if somethingis defined as “nano. ” FDA currently regulates according to product, not process, andin this case, the definition of nanotechnology might not be important for regulation. Butmany argue that there should be a different set of requirements given the public claimthat nanotechnology and nanoproducts are new, have distinct properties, and allow us todo special things. Regardless, developers should not tell the public that nanotechnologyis unique and thus will provide great benefits, and then turn around and tell them that aspecial regulatory look is not necessary. This seeming contradiction may cause a loss inpublic confidence in nanotechnology.It is difficult to agree on a single definition for regulatory purposes, especially because everyagency has to define nanotechnology in its own way based on the statutory authority it has.As a historical example, the Coordinated Framework for Biotechnology has operated for20 years with different definitions of biotechnology in the federal agencies. However, manyargued that definitions matter for other reasons, for example, so different disciplines havea common language for working with each other. Appreciating the way that words requiremeaning is important for communicating among disciplines and with the public. However,the public will perceive or define what nanotechnology is in its own way, and scientists andregulators have little control over definitions in this sphere.37

The group generally agreed that we should change the use of “nanotechnology” for thisfield to “nanotechnologies” given the vast diversity of techniques and applications. Therewas also general agreement that definitions are important for particular conversations, suchas those at the workshop, so participants know the focus of dialogue. However, energy andresources could be misspent coming up with a single, universal definition.• The use of the term “nanotechnologies” should be promoted in place of“nanotechnology.”• Different definitions of “nanotechnologies” may be necessary for different federalagencies due to various statutory authorities.• Definitions for particular dialogues are appropriate; however, resources could bemisspent coming up with a single, universal definition.Governance MechanismsQuestions about governance were the focus of the workshop, and the group consideredoversight paths for nanotechnologies applied to biological systems. Every new technologygoes through a phase where society has choices in oversight mechanisms, and fornanoproducts, paths to governance have not been completely figured out. There ishistorical precedence for defaulting to systems that are already in place, and this is a choicefor nanotechnologies. Other choices include rethinking current systems and redesigningthem to better fit nanoproducts. Regardless, many participants stressed the need forgreater interactions among policymakers, toxicologists, regulators, and developers ofnanomaterials to address challenges with their oversight.For nanoproducts, jurisdictional issues are important, as there are so many productsemerging in the marketplace today. Overlaps or gaps among agency authorities need to beconsidered and addressed, such as the lack of required pre-market testing for cosmetics andfoods.Because of delays in new rule making at the federal level, many participants stressed theneed for interim, voluntary guidelines, as it is easier to formulate than to issue regulations.The group discussed whether there should be a ban on certain types of research, onesfor which there are significant unknowns about the consequences. For example, in themid 1970s with recombinant DNA technology, scientists got together at the Asilomarconference and placed some restrictions on their work until more information could beobtained. At the workshop, the question arose about whether the same caution is neededfor laboratory work given occupational health hazards associated with nanoparticles.The participants also discussed whether it is appropriate to put restrictions on researchthat may lead to applications that have great social consequences. Either way, interimproduction and use standards have a role to play, especially at the international level. Inmanufacturing and industry, the International Standards Organization (ISO) and AmericanNational Standard Institute are developing standards for nanotechnologies. However, inthe end, solid government regulation builds trust and can be industry’s friend. Many at theworkshop noted that the public has more confidence in mandatory systems.38

These and other specific ideas for governance from the presentations and dialogue are listedbelow.• Safety and toxicity issues should be discussed in open and multi-disciplinary settingsbefore the widespread use of nanoparticles.• New strategies in toxicology are needed to address the fact that nanomaterials haveunique properties. Risk assessment paradigms may be the same, but the specialproperties of nanomaterials suggest that data and information needs for ensuringsafety will be different.• Governance frameworks for products of other technologies should be analyzed inorder to learn from their lessons and assess their relevance to nanoproducts.• Amending or developing new regulations and statutes is unlikely in the short, andpossibly long term; therefore, creative ways to ensure that nanotechnology is usedresponsibly are needed. Voluntary programs and industry standards and guidelinescan provide a bridge for ensuring health and environmental safety, but theyshould not be considered a permanent fix, as they will not ultimately foster publicconfidence.• EPA needs additional resources to bolster its abilities to provide oversight fornanoproducts. The agency has multiple roles of funding research, risk assessment,and product safety review. Additional institutional capacity is needed to keep abreastof science and development in nanotechnology.• FDA is challenged by limited statutory authority for some nanoproducts (e.g.,cosmetics) and a lack of basic scientific information about nanomaterials andappropriate scientific tools to evaluate them.• It is important to both consider the current and potential gaps in the regulatorysystem, as well as the general approach that we want to take towards regulation.• The relevance of non-governmental oversight, such as liability and insurancesystems, should be examined in the context of nano-bio products.• Nanomaterials might not be considered new under TSCA, if the molecular structureor formula is the same as those already on the list. This could lead to gaps inoversight of health and environmental safety issues for nanomaterials. Engineerednanomaterials should be considered new regardless of whether its molecularstructure of formula is “new,” with the exception if their chemical and physicalproperties are demonstrated to be the same.• EPA should provide nanomaterial producers with guidance on data that shouldbe provided with PMNs, such as basic information on chemical characteristics,environmental fate and transport, and toxicity.• The same things that make nano-drugs attractive also present special concerns.These concerns need to be kept in mind when a process is developed in industry,as workers are on the frontlines, and there is not sufficient guidance for manynanomaterials.39

Social Context and Public EngagementSeveral participants stressed that public engagement in governance is needed and that thereshould be feedback mechanisms for public engagement early and often. The public shouldhave input on the types of research and commercial products that are developed. Yet thereare significant challenges to public engagement, including how to do it right and how tofactor it into regulatory decisions (e.g., legal statutes do not allow for this). Others notedthat early public engagement might not always be beneficial to industry, or even society as awhole. Some argue that this has been the case for embryonic stem cells in the United States,where the technology has been highly politicized and restricted. So, if the public is engagedin decision making, society might not get answers that are best for reaping benefits of thetechnology.Public engagement in risk analysis was considered. Technical risk assessments giveinformation on the magnitude and types of risks, but they cannot determine what“acceptable” levels of risk are. Different publics and cultures will view the samequantitative or qualitative risk differently. Risk perception leads to various interpretations,affected by whether people understand the risk, can control it, and choose to be exposed. 16These all determine the severity of the consequences in the public eye. People care aboutequity, controllability, choice of exposure, time frames, intergenerational effects, anduncertainty when it comes to risk. Also, if there are greater rewards, people will likelyaccept greater risks (e.g., use of nanoparticles that can target cancer cells).Traditional risk assessment paradigms have been focused on the need to be science driven,or based on “sound science.” There has generally been a linear progression in that theresults of risk assessments are handed to risk managers who make decisions. Then, thesocial context comes into play during the risk communication phase. However, there is acurrent wave of thinking that stakeholders and citizens should be more involved in settingthe questions asked by analysts and helping to interpret them in their social context. 17 Inaddition, risk-based paradigms are ineffective if there is no mechanism to ensure the publicavailability of the data needed to evaluate risk. Currently, there are not good institutionsfor public engagement. Independent bodies of experts who people trust and with whomthey can openly communicate are needed.Goals of public engagement in risk analysis and governance can include either betterregulation in a utilitarian sense or simply choosing the right thing to do from an ethicalperspective. Although public participation in setting questions and providing knowledgefor risk analysis is important, the public should not be forced to argue in the contextof scientific or technical risks. There are multiple issues that concern people—thenotion of what is natural and what is not, corporate control of technology and society,commercialization of science, government secrecy and impacts on trust, and howtechnology will affect their communities. There should be opportunities for discussion16Slovic, P. “Perception of risk.” Science 236: 280-285 (1987)17National Research Council. Understanding Risk. (1996).40

of these issues, so that they do not get confused with the technical risks and benefits tohuman health and the environment. Finally, there are good and bad ways of doing publicparticipation. If the public is engaged, they should either have some ability to influence theoutcome or at least know that many perspectives were considered in making decisions.Transparency and honesty in governance is needed. Mistakes have been made withprevious technologies. For example, it is difficult to get information on the regulationof biotechnology products, in part due to confidential business information (CBI). Thisproblem might be magnified with nanoproducts, where the very chemical nature couldbe CBI. Currently, it is difficult to find out what is coming down the pipeline in thenanotechnology industries due to intellectual property rights and CBI. We need to considerhow to balance the benefits of intellectual property protection with better transparency ingovernance.In an international context, the future will be increasingly global. There are greatglobal challenges associated with food, water, equity, the environment, and security.Nanotechnologies can play important roles in addressing these challenges. However,in the absence of institutions that can focus on societal contexts, it will be difficult tocome to agreement on the appropriate use of technology. Better social institutions at theinternational level are needed for diplomacy, people to relate to each other, to work withothers, and to understand different cultural perspectives.Cultural differences will come into play with respect to applications for extendinglife, human enhancement, or privacy. Social and ethical issues not directly related tonanotechnologies will likely become associated with them. The emerging “nanosciencebiotechnology-informationtechnology-cognitive science (NBIC)” interface and effortsto enhance human performance might fly in the face of what some people believe isan acceptable limit to science and challenge the notion of what it means to be human.Application of nanotechnologies such as these might be feared or perceived negatively bythe public, and therefore, all applications might become tainted. Ethical debates shoulddistinguish among various applications, and not only include utilitarian ethics, butalso intrinsic questions about playing “god,” rights to know and choose, and equitabledeployment of technology.The societal context for nanotechnologies was a focus of the workshop. Below areseveral conclusions and recommendations from the presentations and general workshopdiscussions.• “Risk” means not only health and environmental effects, but also has structuraland perception components. It is not limited, in the public’s eye, to technical riskassessments.• Groups will mobilize against nanotechnology if we continue to fail to address thesocial and ethical issues.41

• Conversations about nanotechnology should not be confined to science andsafety. There are other important issues in nanotechnology governance, such asthe structure of industry, equity of technology deployment, life-cycle of products,consumer rights, appropriate limits of technology, and power and control over thetechnology.• Industry is generally aware of the importance of public perception and the value ofproceeding with caution.• Although public engagement is important, the oversight process should not be drivenby fear, as unnecessary heavy regulatory burdens could have profound effects onsmall companies and limit nanomaterial development to large industry.• To increase transparency, basic information on nature and toxicity of nanomaterialsshould be in the public record before entering the market.• Public aspects of transparency, good governance, and a mature understanding of thefield can make locations attractive for business by reducing potential uncertainty inresearch activities.• Increased consumer attention to upstream food production processes is leading manyto question whether and how to integrate process based concerns into a governancesystem that is largely product and safety based. Issues concerning the structure ofagriculture, power distributions, rights of consumers, and ultimately, what is in thebest interest of the public, are likely to emerge as nanotechnology is applied to foodand agriculture. They require attention and consideration.• Novel social and ethical issues will likely arise from the far-future applications ofnanotechnologies, especially at the nano-bio interface. As a society, we need to beginto consider such issues, while stretching our minds about what possible applicationswill emerge.• There are needs to reframe the interface of nanotechnology with society. Currently,the technology is seen as “having impacts” on society, but in reality, the technology“interacts” in many ways with society, and these interactions are not unidirectional.• Understanding interactions between nanotechnology and society is best achievedby bringing multiple different disciplines into fruitful exchange. However, thereare barriers in universities to multidisciplinary research, such as reward and tenuresystems, and these barriers should be overcome.• Better social institutions are needed for diplomacy; people to relate to each other;and discussing social, ethical and political issues surrounding the nano-bio interface.42

Communication and EducationIn studies presented at the workshop, the public seems to want more information aboutnanotechnology. Participants discussed needs in communication and education, such as a“citizen school” about nanotechnology. Outreach could be done through local libraries,YMCAs, science museums, and community groups. There were suggestions to get studentsinvolved in education and thinking about social issues. Citizens generally want to learnmore and have the capacity to do so, but experts and policy makers need to be willing toengage with them, listen, and educate.Right now, there is a lot of hype about the promise of nanotechnology, and developers needto be careful about what they promise that the technology can do. Hype can ultimatelylead to adverse public reaction, and the public can generally see through it, especially ifthey are not directly experiencing the benefits. There is a need to be cautious of oversellingnanotechnology. Independent voices for education and communication are needed.• Communication about nanotechnology will impact how the public viewsnanotechnology, and ultimately it will affect the governance of it.• Images of nanotechnology are important for public communication.• Independent voices are needed for education and communication.• Communicating hype about the promise of nanotechnologies should be avoided.Research AgendaResearch funding is an integral part of technology governance. In the workshopdiscussions, many pointed out that more funding is needed for research on the implicationsor impacts of nanomaterials. There is also a need for applications research to be tiedto implications, and the two should be integrated in the federal research agenda. Onespecific implications research need is long-term toxicity tests on and testing protocols fornanoproducts. Some participants suggested that a coalition of industry, NGO, government,and academe should consult and jointly fund safety work.Other research needs that were suggested include more projects on big, problem-focusednanotechnology and on societal implications.• Implications research should be distinguished, as much as possible, from applicationsresearch and given considerably more attention and funding.• To solve great societal problems, structural changes in research funding are needed.Funding organizations should shift some of their focus and invest larger amounts inproblem-focused nanoscience, such as clean energy, water sanitation, and disasterprevention.43

• Funding for research on societal contexts for nanotechnology and public engagementmethods should be increased.• Aerosol technology should be considered as a model for better understandingnanotechnologies, their applications, and risks. It is a mature field that is rich withdata and methods.Concluding RemarksThe conference was successful in highlighting the various oversight opportunities andchallenges at the nanotechnology-biology interface. We hope it is just a step towardscontinuing dialogue and activity on this topic.44

Appendix —Discussion Group Participants 19*Norris Alderson, Associate Commissioner for Science, FDA*Davis Baird, Professor of Philosophy, Nanoscience and Technology Studies, Societal andEthical Implications, University of South Carolina*Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C., Washington, DCDan Burk, Professor of Law, University of Minnesota*Jacob N. Finkelstein, Professor, Environmental Medicine and Radiation Oncology,University of Rochester School of Medicine*Karen Florini, Senior Attorney, Environmental Defense, Washington DC*Sheldon K. Friedlander, Parsons Professor of Chemical Engineering, UCLAGene Goddard, Biosciences Industry Specialist, MN Dept. of Employment and EconomicDevelopment*Darrel Gubrud, President, Gubrud Consulting, MN Nanotechnology InitiativeKen Hallberg, MN Nanotechnology Initiative*Robert Hoerr, CEO, Nanocopoeia, Inc., Minneapolis, MNRobbin Johnson, Senior Vice President, Cargill, Inc.*Kenneth H. Keller, Charles M. Denny, Jr. Professor of Science, Technology, and PublicPolicy, Humphrey Institute, University of MinnesotaSteven J. Keough, Vice President, Surmodics, Inc.Jacques Koppel, The Koppel Group, Inc.*Jennifer Kuzma, Associate Director and Assistant Professor, Center for Science,Technology, and Public Policy, Humphrey Institute, University of Minnesota*Jane Macoubrie, Senior Visiting Scholar, Woodrow Wilson International Center forScholars*Evan Michelson, Research Associate, Project on Emerging Nanotechnologies, WoodrowWilson International Center for Scholars45

Deb Newberry, Director, NanoScience Program, Dakota County Technical College, MNJordan Paradise, Associate Director for Research and Education, Consortium on Law andValues in Health, Environment, and the Life Sciences, University of Minnesota*Christine Peterson, Vice President for Public Policy, Foresight Institute*David Pui, Distinguished McKnight University Professor, Particle Technology Laboratory,University of MinnesotaGurumurthy Ramachandran, Professor, School of Public Health, University of Minnesota*Nora Savage, Environmental Engineer, Office of Research Development, National Centerfor Environmental Research, EPA*Richard H. Smith, President, Nanotechnology Network Principal, Nanoverse LLC, andco-founder Nanotechnology Policy FoundationJohn Stone, Research Associate, Institute for Food & Agricultural Standards, Michigan StateUniversity*Andrew Taton, Professor, Department of Chemistry, U of MNKana Talukder, Research Assistant, Center for Science, Technology, and Public Policy,University of Minnesota*Paul Thompson, Professor of Philosophy, W. K. Kellogg Chair in Agricultural, Food andCommunity Ethics, Agri-food Nanotechnology Program, Michigan State University*Darrel Untereker, Vice President of Corporate Research and Technology, MedtronicPeter VerHage, Research Assistant, Center for Science, Technology, and Public Policy,University of Minnesota*Larry P. Walker, Professor, Dept. of Biological and Environmental Engineering, CornellUniversityElizabeth Wilson, Assistant Professor, Center for Science, Technology, and Public Policy,Humphrey Institute, University of Minnesota*Alan S. Ziegler, Member of the Board of Directors of the Converging Technologies BarAssociation and Attorney with Sweeney Lev LLC, Montclair, New Jersey19The discussion group includes presenters and other participants who met on the day following the publicworkshop. Presenters are denoted with an asterisk. Views expressed in this document do not necessarily reflect theopinions of each individual listed here or the organizations with which they are affiliated.46

AcknowledgementThe editor gratefully acknowledges Marsha Riebe and C. Sophia Albott of the Center forScience, Technology, and Public Policy for carefully proofreading the final report.47

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